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Use of Cyclobenzaprine After Vaginal Surgery

The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01081990
Enrollment
63
Registered
2010-03-05
Start date
2010-04-30
Completion date
2014-08-01
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

The management of post-operative pain in patients after vaginal surgery provides many unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach for the repair of pelvic floor prolapse and urinary incontinence, patients may still experience varying degrees of discomfort and post-operative pain. Narcotics, however, can introduce a host of problems in addition to the potential addictive properties of the medication. A vicious cycle ensues as patients seek better pain control at the expense of worsening constipation, but without adequate control of pain after surgery, voiding dysfunctions are often exaggerated. Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management of acute musculoskeletal injuries, but the practice of prescribing this centrally acting muscle relaxant for post-operative patients has also been successful in the management of pain. An online search of medical databases revealed that there are currently no published retrospective or prospective studies determining the efficacy of cyclobenzaprine in post surgical patients in conjunction with traditional pain management. The investigators hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently, the reduction of narcotics and the control of post-surgical pain may also hasten the return of normal urinary and defecatory function.

Interventions

Cyclobenzaprine 5 mg TID for 7 days

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Ages 18-70 years old * Undergoing vaginal surgery with apical or posterior repair requiring hospitalization * Willingness to participate in the study * Normal neurological exam * English speaking

Exclusion criteria

* Contraindication to NSAIDs * Allergy to hydrocodone, hydromorphone, or cyclobenzaprine * Renal disease * Use of any antidepressants including SSRI, SNRI, MAOI in the last 3 months * Glaucoma * Diabetes * Hyperthyroidism * Uncontrolled hypertension (\>160/100 mm Hg) * History of chronic narcotic use in the last 3 months * History of pelvic pain

Design outcomes

Primary

MeasureTime frame
Faces Pain scale2 weeks
Quantity of pain medications2 weeks

Secondary

MeasureTime frame
Constipation scale2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026